MULTI-LUMEN CV CATH KIT AK 14703 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-02 for MULTI-LUMEN CV CATH KIT AK 14703 N/A manufactured by Arrow International: Precision Biomed.

Event Text Entries

[1314] Retained guidewire. Date of actual retention unknown at this time. Patient has had two (2) central lines placed. One on 7/16/92 on a previous admission. The x-ray does not note a retained wire. The patient had another placed 8/12/92. While reading the x-ray for placementdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1671
MDR Report Key1671
Date Received1992-11-02
Date of Report1992-10-20
Date of Event1992-08-12
Date Facility Aware1992-10-06
Report Date1992-10-20
Date Reported to FDA1992-10-20
Date Reported to Mfgr1992-10-13
Date Added to Maude1992-11-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMULTI-LUMEN CV CATH KIT
Generic NameCENTRAL LINE
Product CodeGBP
Date Received1992-11-02
Model NumberAK 14703
Catalog NumberN/A
Lot NumberUNKNOWN
ID NumberN/A
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key1587
ManufacturerARROW INTERNATIONAL: PRECISION BIOMED


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-11-02

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